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Growing Regulatory Complexity: An Innovation Challenge?

Leveraging collaboration, a quality of culture, and new technologies such as AI could help companies improve regulatory performance.

Image by Gerd Altmann from Pixabay 

 The considerable rise in regulatory complexity within the global medical device manufacturing community is a challenge that keeps many leaders rethinking the right approach. While the European Union’s Medical Device Regulation (EU MDR) is at the forefront today, the issue certainly isn’t limited to the EU.

Life sciences organizations have a choice with regulatory initiatives: spend the minimal amount to be compliant and live with a patchwork of “silo solutions” or look at challenges such as EU MDR as an opportunity to innovate and modernize information management practices. The increasing complexity of regulatory compliance requirements is consequential and requires a strategic, holistic versus tactical approach to deliver ROI over the long term.

 

Internal Factors May Intensify the Challenge

In addition to external pressures, many device companies have internal challenges that intensify the issue. A 2018 Gens and Associates study of 72 companies revealed these factors that complicate the regulatory compliance roadmap for device participants:

  • 72% report inefficiency with key regulatory information management capabilities such as submission document management, registration management, health authority interactions, and label compliance tracking.
  • 60% take longer than a week to report key regulatory information (e.g., regulatory status of products at a specific manufacturing site, status of label changes at the local affiliate office, and health authority commitment status) due to information fragmentation.

Furthermore, many organizations have undergone significant M&A activity and often delay integration of processes and systems. Operating structures are often regionally-focused. Investments at the global level are less frequent, limiting global visibility and knowledge sharing. Many use disparate systems, which create information silos that prevent regulatory teams from drawing insights about the ‘big picture.’

Taking a More Holistic Approach

Companies are exploring more efficient and effective regulatory organizations and capabilities. They are leveraging innovation and new organizational strategies to drive more cost-effective regulatory performance as well as reduced cycle times through:

  1. More Effective Collaboration throughout the Product Life Cycle

    An organization’s regulatory team should play a pivotal role in product lifecycle decision-making. Ensuring that the regulatory team communicates early and frequently with R&D, clinical operations, manufacturing, labeling, and others will improve overall speed to market and compliance. For example, a regulatory team’s proactive input on the probability of regulatory success can influence product portfolio decisions and minimize costly spending on low potential products. This group can advise design teams on specific health authority requirements to maximize design efficiency by creating a “global” product. Strong collaboration between regulatory and manufacturing groups can result in better decisions about manufacturing changes that will support compliance and speed the change agenda.
     

  2. Global Centralization of Regulatory Services

    Successful organizations consider the optimal location for each of the activities they perform. A local regulatory footprint is helpful to maintain strong health authority relationships and feet-on-the-ground understanding of local requirements and market nuances. However, centralization is paramount to enable efficiency, compliance, and profitability. While not all activities can or should be centralized, even partial centralization can produce benefits:

    • Economies of scale.
    • Knowledge sharing.
    • Global adoption of leading practices.
    • More consistent content and messaging.
    • Improved availability and accuracy of data for reporting.

    Many life sciences organizations find efficiencies centralizing global regulatory intelligence and knowledge management, regulatory analytics, RIM/registration management, submission publishing (especially electronic submissions), labeling, correspondence management, commitment management, and submission planning and tracking.
     

  3. Building a Culture of Quality

    In an environment of increasing competition, regulations, and customer expectations, many life sciences leaders are being intentional about cultivating a culture of quality. They foster this culture not only to be compliant; they use it as a clear differentiator in the market and a way to improve bottom line results. For instance, as a collaborator with the Medical Device Innovation Consortium (MDIC) and FDA, Grant Thornton works to identify and share practices that elevate quality. Research suggests that a company with an embedded culture of quality spends, on average, $350 million less annually fixing issues than a company with a poorly developed one.1

    Key quality culture characteristics include: 

    • Data about quality is proactively collected and shared in a transparent manner. 
    • Management sets clear quality objectives.
    • Quality issues are remediated quickly.

    • Management looks at leading indicators of quality, not just at lagging indicators.
    • Employees stay up-to-date on current guidelines and regulations as well as trends. They consider not just the narrow wording of regulations, but the broader intent.
    • Management prioritizes a continuous improvement focus and challenges the status quo.
    • The company collaborates openly with stakeholders, such as providers and patients, to identify improvements.

    This shift in mindset cannot happen overnight. Rather, it’s an evolution that requires strong executive leadership and buy-in throughout the entire organization.
     

  4. Using Technology as an Enabler

    Many device companies are exploring ways to apply innovative software technologies to overcome environmental and internal hurdles.  (See below for details on what technologies companies are leveraging.) 
     

    Source: Gens and Associates 2018 Benchmarking Study

    For example, artificial intelligence (AI) provides a unique opportunity to mine sources, such as interactions with regulators, health authority correspondence, audit findings, and more, to create a more comprehensive regulatory intelligence landscape.

    Some companies are using AI to identify unpublished requirements within correspondence, capture local country experience, and effectively synthesize intelligence. Previously, regulatory staff may have tried to capture details from these sources in an Excel file and then search the spreadsheet to find references. These searches were not just time-consuming—they were unlikely to uncover relevant facts. With AI, companies can automatically search multiple repositories for relevant details. AI solutions continuously learn so the searches return moretargeted results each time.

Although competitive and regulatory pressures continue to mount, medical device organizations that take advantage of transformative improvements can imagine a bright future. By enhancing collaboration, embracing a quality of culture, centralizing relevant regulatory activities, and using technology to drive innovation, there is reason to look forward with anticipation. Organizations that do will enjoy improved speed to market, greater customer loyalty, and stronger bottom-line results.

Reference

1. Harvard Business Review, April 2014

John Cassimatis, Lisa Cooney, Steve Gens, and Pat Shafer

John Cassimatis, Lisa Cooney, Steve Gens, and Pat Shafer

John Cassimatis serves as Grant Thornton’s Life Sciences Business Consulting sector leader. Before joining Grant Thornton, Cassimatis was co-founder and president of TayganPoint Consulting Group, which Grant Thornton acquired in October 2018. He has more than 30 years of experience advising and working with some of the world’s leading corporations in life sciences and other industries, assisting with major organizational transformations. His areas of expertise include strategy formulation and implementation, business process improvement, organizational re-design, change management, and information technology strategy. Cassimatis has led global business transformation initiatives primarily focused on the life sciences sector, including pharmaceutical, medical device, and healthcare consumer products. His functional experience includes R&D, regulatory, supply chain, commercial, quality & compliance, finance, IT, and shared services.

Lisa Cooney is a trusted advisor with significant experience leading global transformations. A director in Grant Thornton’s Operations Transformation practice, she has deep expertise in process excellence, program leadership, change management, communications, and training. Cooney has more than 25 years of experience in life sciences. As a consultant, she has led projects in regulatory affairs, clinical research, supply chain, and operations resulting in transformative success and strong employee engagement. Before joining Grant Thornton, Lisa spent 18 years at IQVIA, running enterprise-wide quality and LEAN Sigma programs. Her experience there culminated in a role as vice president, process engineering, where she created and led the global LEAN Sigma program.

Steve Gens is the founder of Gens and Associates, a boutique life sciences information management and organizational consultancy specializing in strategic planning, industry benchmarking, regulatory information management, organizational effectiveness and transition management. His company has worked with 80% of the top 50 bio-pharmaceutical companies worldwide, small growing bio-pharmaceuticals, medical device, consumer product, regulatory software/service providers, and the investment community. Gens has more than 30 years of business experience, having spent his early career at Waterford Crystal and Johnson & Johnson before moving into consulting, where he managed several global healthcare consulting practices for Booz Allen Hamilton and First Consulting Group. He has deep strategy formulation, organization development, industry benchmarking, and information management strategy expertise.

Pat Shafer is a managing director in Grant Thornton’s Healthcare and Life Sciences practice. During his career, he has led scores of strategic and tactical projects including global roadmaps; launch readiness assessments; Quality, Regulatory, Clinical, and Pharmacovigilance capability maturity assessments; as well as knowledge management and performance measurement initiatives. For the last several years, Shafer has been a key contributor to FDA’s Voluntary Incentive Program for reimagining how the agency, particularly CDRH, exercises review and oversight of medical devices by leading competency and metrics workstreams within the Case for Quality, a collaboration effort between FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry. Shafer has helped new companies develop core processes to enable successful submissions and compliant release of products, as well as helped industry leaders reengineer established processes to achieve exceptional gains in speed to market and operational efficiency. He has also developed the regulatory strategy for registration of Mobile Medical Applications and led discussions with FDA’s CDRH on these matters.

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